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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

Please review the Safety Rules and Guidelines.
Thursday, April 12 • 1:30pm - 5:30pm
Workshop 13 - GLP 202: Regulatory Surveillance Inspections (1/2 day)

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RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course provides an overview of the FDA surveillance inspection process, in particular as it applies to GLP facilities. This course describes how to prepare for an agency inspection, how to host the inspection, and how to interact with regulators during and after the inspection. Additionally, this course will touch on the Canadian accreditation/ re-accreditation inspection process.

Objectives
At the end of the course, the participants shall be able to: 
  • Prepare for an agency inspection
  • Host an agency inspection
  • Understand FDA's current thinking and approach during inspections
  • Understand Canada's accreditation/re-accreditation process

Target Audience
This course is targeted to personnel (e.g. management, auditors, study personnel) who participate in regulatory agency inspection readiness activities and/or hosting regulatory inspections.

Agenda
  • Inspection readiness
  • Hosting regulatory inspections
  • Investigator's approach during inspections
  • FDA regulatory expectations and current thinking
  • Canada re-accreditation inspections


Speakers
avatar for Jennifer Bravo

Jennifer Bravo

Senior QA Manager, Charles River Laboratories
Jennifer Bravo is Senior QA Manager at Charles River Laboratories Worcester, MA. The Worcester site provides GLP Bioanalytical and Immunoanalytical services. In her current role, Jen oversees various aspects of the site’s quality systems, including internal audit program, vendor... Read More →
DC

Dominique Chan

Manager of Regulatory Compliance, Charles River Laboratories
Ms Dominique P. Chan is Manager of Regulatory Compliance who currently oversees the Lab Science team of QA auditors. She currently manages a team of 13 auditors, whose main focus is on the various lab datasets, including clinical work. Other key responsibilities include monitoring... Read More →
avatar for Sherry Lee Dawson

Sherry Lee Dawson

Manager, Regulatory Compliance, Charles River Laboratories Montreal ULC
Sherry Lee Dawson, is a Quality Assurance Manager at Charles River Laboratories Montreal ULC, a safety assessment site conducting GLP studies. In this role she oversees various projects, including Regulatory Inspections, Sponsor Audits, Vendor Audit program for her site, quality metrics... Read More →
avatar for James Farmer

James Farmer

Sr. Manager, Regulatory Compliance, Charles River
James Farmer is the Sr. Manager, Regulatory Compliance at Charles River Laboratories – Nevada, a safety assessment site conducting GLP studies. In this role he is responsible for the Quality Program of the Nevada facility to include overseeing various projects such as Regulatory... Read More →
NS

Nina Sahay

Senior Quality Assurance Specialist, Charles River Laboratories
Nina Sahay B.S., RQAP-GLP is the Senior Quality Assurance Specialist at the Skokie facility of Charles River Laboratories. Her primary responsibilities are to assure compliance with the Good Laboratory Practice Regulations and laboratory Standard Operating Procedures at CR. Her 14... Read More →


Thursday April 12, 2018 1:30pm - 5:30pm
Platinum 1&2

Attendees (12)